Received Apr 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
suspected vaccination failure; got again later; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. The patient's past medical history included respiratory syncytial virus infection. On an unknown date, the patient received RSV vaccine. On an unknown date, less than a year after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: got again later). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was resolved. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 17-APR-2025 This case was reported by a patient via interactive digital media. The patient got Respiratory Syncytial Virus vaccine. The patient got one respiratory syncytial virus infection but had it right before the shot, could take effect and turned serious. The patient got respiratory syncytial virus infection again later in year very mild quick recovery. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (h/o respiratory syncytial virus infection, insufficient information regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine.
Medical History/Concurrent Conditions: Respiratory syncytial virus infection